BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    TRACTUS TISSUEMAPPER IMAGE RECORDING SYSTEM APPLICATION

    FDA 510(k)
    FDA Class 2 ·Radiology

    ArgenIS

    FDA UDI
    ARGEN CORPORATION, THE·D818131489·TiBase NR 6.0 .3G E

    PITANGA

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ORION

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    TRUEBEAM STE

    FDA Adverse Event
    Malfunction ·VARIAN MEDICAL SYSTEM, INC.·Product code IYE·May 13, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 1, 2014

    CARELINK PROGRAM W/TELEMETRY C

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code DXY·June 16, 2011

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020